Impact of Suture Technique on Wound Healing in Ankle Fracture Surgery: A Randomized Controlled Trial

July 3, 2024 updated by: University of Puerto Rico

Our primary aim is to compare the complication rates of patients with ankle fractures who underwent skin closure using a running subcuticular suture pattern compared to an interrupted suture pattern. At the time of the operation, participants will be assigned to either the Subcuticular Suture Group (SSG) or the Simple Interrupted Suture Group (SISG) using computer-generated randomization programs. The surgeon will perform the assigned closure technique using standardized techniques. Running subcuticular Vicryl 3-0 sutures will be placed on patients in the experimental group while simple interrupted Monocryl 3-0 sutures patients in our control group.

Patients will be followed up at the two-week and eight-week postoperative mark where we will use the Patient and Observer Scar Assessment Scale (POSAS) to evaluate and compare wound healing. Additionally, photographs of the scars will be captured to visually assess the healing progression.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 21 years or older with isolated ankle fractures requiring surgical intervention and who consent to participate.

Exclusion Criteria:

  • Patients that will be excluded from this study include those with complex ankle fractures, open fractures, a history of wound healing disorders, and/or those unable to provide consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subcuticular Suture Group
Running subcuticular Vicryl 3-0 sutures will be placed on patients in the experimental group.
Procedure: Subcuticular Suture
In the experimental group, subcuticular sutures will be used for wound closure after surgical repair of ankle fractures.
Active Comparator: Simple Interrupted Suture Group
Simple interrupted Monocryl 3-0 sutures will be placed on patients in the control group.
Procedure: Simple Interrupted Suture
In the control group, simple interrupted sutures will be used for wound closure after surgical repair of ankle fractures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complication rates
Time Frame: 2 and 8 weeks post-op.
Complications include wound infection, dehiscence, suture breakage, suture abscess, necrosis, allergic reactions, malunion, hardware failure, and the need for reoperation or revision surgery.
2 and 8 weeks post-op.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: 2 and 8 weeks post-op.
The Patient and Observer Scar Assessment Scale (POSAS) is a comprehensive tool used to evaluate the quality of scars from both the patient's and observer's perspectives. It consists of two parts: the Patient Scale and the Observer Scale.
2 and 8 weeks post-op.
Self-reported foot and ankle score (SEFAS)
Time Frame: 2 and 8 weeks post-op.
Consists of 12 items related to pain, limping, swelling, and use of orthotics and walking.
2 and 8 weeks post-op.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Puerto Rico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2024

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 15, 2026

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

July 3, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 117966

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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